Role & Responsibilities
IPQA & Manufacturing Oversight -
- Perform line clearance activities for new batches, dispensing of raw materials, cell bank issuance, and handling of Drug Substance (DS).
- Provide in-process QA oversight during manufacturing operations to ensure compliance with approved procedures and GMP requirements.
- Review and approve batch manufacturing records (BMRs) and batch documentation for completeness, accuracy, and complianc e.
Analytical QA & Data Integrity -
- Review analytical QC documents and ensure compliance with approved specifications and test procedures.
- Perform audit trail reviews for critical QC instruments and relevant process equipment to ensure data integrity (ALCOA+ compliance).
- Support and manage QA activities using eDMS and other digital quality systems.
Validation & CPV Review -
- Review Continued Process Verification (CPV) data and ensure trending and compliance.
- Review Process Validation Protocols and Reports.
- Review Cleaning Validation Protocols and Reports to ensure effectiveness and regulatory compliance.
Deviation, Breakdown & Complaint Handling -
- Handle breakdown-related QA activities, including acknowledgement and receipt of complaints from user departments.
- Support investigation, documentation, and closure of quality events related to manufacturing and QC operations.
Documentation & QMS Support -
- Prepare, review, approve, and control SOPs and quality documents in line with QMS requirements.
- Ensure timely documentation, version control, and compliance with regulatory expectations.
Qualification
- M.Pharm or M.Sc (Chemistry / Biotechnology / Microbiology or related discipline)
Experience
- 2 to 6 years of experience in biopharmaceutical industry
Skills & Competencies
- Strong experience in IPQA activities and analytical document review
- Sound knowledge of cGMP and data integrity principles
- Experience with eDMS / electronic quality systems
- Good understanding of validation, CPV, and batch documentation
